ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Synchrony in the Post-operative Patient (SYNCHRONY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01771341
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : January 22, 2015
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Neurally adjusted ventilatory support improved synchronization in the medical patient. However no data are available in the postoperative patient.

This way the investigators designed a prospective randomized cross over trial to evaluate this issue in the abdominal post-operative patient.


Condition or disease Intervention/treatment Phase
Patient-ventilator Asynchronism Device: MAQUET SERVOi ventilator with Edi Catheter Device: MAQUET SERVOi ventilator Not Applicable

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of Synchrony in the Post-operative Patient (NAVA vs Pressure Support)
Study Start Date : February 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014
Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Placebo Comparator: Pressure support Device: MAQUET SERVOi ventilator
Pressure Support
Other Name: Pressure Support
Experimental: NAVA Device: MAQUET SERVOi ventilator with Edi Catheter
NAVA respiratory modality
Other Name: Neurally Adjusted Ventilatory Assist


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Asynchrony index (AI) [ Time Frame: 8 hours ]
    Number of asynchrony events/total respiratory rate


Secondary Outcome Measures :
  1. PaO2/FiO2 ratio [ Time Frame: 8 hours ]
    ratio of partial pressure arterial oxygen and fraction of inspired oxygen


Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult > 18 yr-old
  • abdominal post-operative patient
  • able to trigger the ventilator

Exclusion Criteria:

  • infant
  • pregnancy
  • esophageal surgery
  • recent esophageal variceal bleeding
Contacts and Locations
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771341


Locations
France
Hospices Civils de Lyon- Centre Hospitalier Lyon Sud
Pierre Bénite, France, 69310
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Florent WALLET, MD Hospices Civils de Lyon
More Information
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01771341     History of Changes
Other Study ID Numbers: 2010.646
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: January 22, 2015
Last Verified: January 2015

Keywords provided by Hospices Civils de Lyon:
NAVA
post operative